The MHRA are holding a GCP Stakeholder engagement meeting on 16th November at our offices in London in order to explore 3 areas of the new Clinical Trials Regulation that require national legislation.
A bite sized summary of our recent posting to the MHRA Inspectorate blog
In part 2 of our series on QP Certification and Batch Release we concentrate on the application of Annex 16 to Investigational Medicinal Products (IMPs)
Are you a new applicant establishing a small wholesale dealers’ operation; and do you need guidance for creating written procedures?
Our GDP inspectors often receive queries from wholesaler distributors asking in what instances agreements are required for the purposes of fulfilling pharmacovigilance requirements.
Last week we published the 1st April 2015 to 31st March 2016 GCP Inspection metrics report.
To help GLP organisations pro-actively improve compliance we are sharing the 2015 inspection metrics and examples also seen over the last 12 months
An update on the use of short notice and unannounced GMP inspections
This post describes the main issues seen when freezers are used by pharmaceutical wholesalers and provides an MHRA GDP inspectors’ view on possible ways to address them.
We have today updated the sidebar of the MHRA Inspectorate Blog to provide access to the MHRA Inspectorate organogram.